Last week brought some upsetting news for people with implanted cardioverter-defibrillators, designed to shock the heart back to normal if it begins beating erratically. ICD maker Medtronic abruptly stopped selling failure-prone electrical leads that attach many of its devices to patients' hearts. Here's some guidance for those patients:
What's the concern? About 268,000 Medtronic defibrillators with Sprint Fidelis leads have been implanted, and an estimated 2.3 percent fractured within 30 months, sometimes resulting in inappropriate shocks or other problems. Many more could fail over time, predicts William Maisel, a cardiologist at Beth Israel Deaconess Medical Center in Boston who has studied defibrillator malfunctions. At least five deaths have been linked to Fidelis-related problems.
What should patients do? See their physicians, who can check for fractures and make certain changes to onboard software. The reprogramming should help identify lead failures before they cause problems. Patients who aren't sure of their lead's model can contact their doctor or Medtronic (800-551-5544).
Should implanted Fidelis leads be replaced? In many cases, no, experts agree: Taking a wire out of the heart can be dangerous. Patients who are at low risk—those who have never suffered cardiac arrest or needed a lifesaving shock—probably should not have their wire changed or removed.
Who might consider getting a replacement? Patients who've previously received a shock or who rely on their ICD as a pacemaker should talk with their physician, Maisel says, since "every beat of their heart might be dependent on that defibrillator and that wire." Even then, doctors may take other individual factors, such as life expectancy, into account. Medtronic's data found that patients younger than 21 who had received Fidelis leads had lower long-term survival rates than peers whose ICDs used another kind of Medtronic lead.